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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

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MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number PB 10
Device Problem Obstruction of Flow (2423)
Patient Problems Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024); Thrombus (2101)
Event Date 01/30/2019
Event Type  Injury  
Manufacturer Narrative
Citation: jewgenow p et al. Subclinical thrombus formation in bioprosthetic pulmonary valve conduits. Int j cardiol. 2019 apr 15;281 :113-118. Doi: 10. 1016/j. Ijcard. 2019. 01. 095. Epub 2019 jan 30. Earliest date of publish used for event date. No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported. Without return of the product no definitive conclusion can be made regarding the clinical observations. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information via literature regarding a histopathologic analysis of explanted bioprosthetic pulmonary valve conduits for subclinical thrombus formation. All data were collected from multiple centers. The study included 47 explanted pulmonary conduits from patients with a history of congenital heart disease and concomitant pulmonary valve stenosis and/or insufficiency. The mean age of the patient population was 5. 6 years. Of the explanted conduits, 39 were medtronic products: hancock (23), contegra (7), melody (7), and freestyle (2). No serial numbers were provided. Among all patients, adverse events included: conduit explantation due to pulmonary stenosis and/or pulmonary insufficiency (observed in hancock, contegra and melody); and subclinical thrombus formation at the base of the valve sinus. It was reported that the duration from conduit implantation to conduit explantation was a mean 63 months (6 to 342 months). Based on the available information, medtronic product was directly associated with the adverse events. No additional adverse patient effects or product performance issues were reported.
 
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Brand NameMELODY TRANSCATHETER PULMONARY VALVE
Type of DevicePULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer (Section G)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key9504845
MDR Text Key172260129
Report Number2025587-2019-03857
Device Sequence Number1
Product Code NPV
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P140017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 12/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPB 10
Device Catalogue NumberPB 10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/20/2019 Patient Sequence Number: 1
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